Feasibility and effectiveness of a lifestyle intervention program in obese endometrial cancer patients: A randomized trial

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Abstract

Objective

The majority of endometrial cancer survivors (ECS) are obese and at risk for premature death. The purpose of this study was to assess feasibility of a lifestyle intervention program for promoting weight loss, change in eating behaviors, and increased physical activity in obese ECS.

Study design

Early stage ECS (n = 45) were randomized to a 6-month lifestyle intervention (LI; n = 23) or usual care (UC; n = 22). The LI group received group and individual counseling for 6 months. The primary endpoint was weight change. Secondary endpoints were physical activity, [Leisure score index (LSI)] and nutrient intake (3-day food records). Quantitative vitamin C and folate intake were used to assess fruit/vegetable intake.

Results

Recruitment was 29%, adherence (LI group) was 73% and 84% of participants completed follow-up assessments. At 12 months, the intervention group lost 3.5 kg compared to a 1.4 kg gain in the control group [mean difference =  4.9 kg; 95% CI: − 9.0 to − 0.9 kg; p = .018] and had an increased LSI score of 16.4 versus − 1.3 in the control group from baseline [mean group difference = 17.8; 95% CI = 7.1 to 28.4; p = .002]. There were no differences in vitamin C and folate intake. The LI group had lower intake of kilocalories, although differences were not significant.

Conclusion(s)

A lifestyle intervention program in obese ECS is feasible and can result in sustained behavior change and weight loss over a 1-year period.

Introduction

Endometrial cancer is the most common gynecologic cancer in the United States and obesity is a significant risk factor for development of the disease. Fortunately, the majority of patients present with stage I disease. The American Cancer Society's publications on cancer statistics suggest an increasing trend in new cases and estimated deaths [1]. Prior reviews since the 1970's found that approximately 30% of patients with endometrial cancer were obese [2], [3], [4]. A recent prospective study reported that 68% of women with early endometrial cancer were obese [5]. It is likely that endometrial cancer incidence is increasing secondary to rising obesity and the aging U.S. population, [6] and that the increased death rate is due to the co-morbidities associated with obesity.

Being overweight at the time of diagnosis has been linked to poorer survival in breast, colon, prostate, and endometrial cancers [7], [8], [9], [10], [11], [12]. Weight can also impact cancer recurrence in breast, colorectal and prostate cancers [8], [9], [12]. The impact of weight on cancer recurrence does not appear to be involved in endometrial cancer, however obese endometrial cancer patients have a higher mortality from causes not related to cancer [7]. What is unknown is whether endometrial survival (all cause) can be improved with healthy lifestyle changes.

Physical activity and survival have been specifically investigated in breast and colon cancers and appears to reduce the risk of mortality [10], [13]. Holmes et al prospectively assessed nurses in the Nurses' Health Study with stage I–III breast cancer [13]. They found that physical activity reduced the risk of death from disease with the greatest benefit occurring in women who walked 3–5 hours per week. Meyerhardt et al found that increasing levels of exercise reduced cancer-specific mortality and overall mortality in women with stage I–III colorectal cancer [10], [14]. Patients included in these studies had a wide range of baseline physical fitness levels and had a mean BMI corresponding to overweight, more typical of the general population.

To improve overall health, cancer survivors frequently initiate lifestyle changes after diagnosis. Previous studies indicate that breast, prostate, lymphoma, lung, and colorectal cancer survivors often lose weight, increase exercise, and increase fruits and vegetables [15], [16], [17]. Unfortunately, women with endometrial cancer do not appear to make positive lifestyle changes after diagnosis and treatment [5]. It is well known that physicians are powerful catalysts for promoting behavior change [18]. A cancer diagnosis and the period thereafter may represent an opportune time for undertaking health behavior change [19], [20]. It has been acknowledged as a life-changing event, therefore, physicians should take advantage of the “teachable moment” a cancer diagnosis provides and guide their patients to better health [19].

Research, mainly in breast cancer survivors, has revealed that lifestyle intervention programs are feasible [21], [22], [23]. Chlebowski et al in the Women's Intervention Nutrition Study (WINS) randomized breast cancer survivors to an intensive dietary intervention designed to reduce dietary fat intake [24]. Results revealed that those in the intervention group lost weight and had improved diet quality relapse-free survival. Demark-Wahnefreid et al in project LEAD examined the effect of a diet and exercise program in breast and prostate survivors. Results showed a significant improvement in diet quality but not in exercise [25]. In terms of physical activity behavior change interventions, Vallance et al in the Activity Promotion Trial found that print materials and step pedometers increased exercise in breast cancer survivors [26].

An effective lifestyle intervention strategy in endometrial cancer survivors is imperative to improve overall health, and to possibly increase survival. Targeting obesity during a teachable moment may be the key to improving cancer survivorship in these women. The purpose of this study was to assess the feasibility of a lifestyle intervention program for promoting weight loss, change in eating behaviors, and increased physical activity in obese endometrial cancer survivors (ECS). We hypothesized that overweight and obese ECS would be interested in a lifestyle intervention and able to make positive behavior changes resulting in weight loss.

Section snippets

Study design and patient recruitment

The study was a prospective, two-group randomized controlled trial comparing a lifestyle intervention (LI) consisting of physical activity and nutritional counseling with behavior modification, to usual care (UC) in overweight and obese endometrial cancer survivors. The 6-month intervention was delivered to the LI group while the UC group received only an informational brochure after randomization ("Better Health and You," Weight Control Information Network, June 2004). To reduce attrition, UC

Results

Participant flow is presented in Fig. 1. Letters were sent to 156 eligible women, 62 (40%) responded and 45 (29%) were ultimately enrolled. Thirteen of the 62 (21%) patients responding were interested but opted not to enroll due to travel distance for weekly sessions. Sample size estimates were based on 50 patients; however, only 45 patients were enrolled by the target date when the intervention program had to begin due to logistical reasons. Therefore, 23 women randomized to the LI group and

Discussion

There are more than 1 million gynecologic cancer survivors in the United States [44] and endometrial cancer patients are the most common [1], [44]. It is imperative to implement lifestyle interventions to improve the survivorship of endometrial cancer patients, who are at increased risk of poor quality of life and premature death [7], [45]. We provided preliminary data to illustrate the feasibility of an interventional lifestyle program in endometrial cancer survivors as the intervention group

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    Source of support: This research was supported by a grant from the Lance Armstrong Foundation.

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